FDA.reportPublic FDA data

NDC 16729-394 - amlodipine besylate and olmesartan medoxomil

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
16729-394
Package NDCs from labels
16729-394-10, 16729-394-15, 16729-394-16, 16729-394-17
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2019-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POVIDONE K30 - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2019-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-394-10amlodipine besylate and olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED302
16729-394-15amlodipine besylate and olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED902
16729-394-16amlodipine besylate and olmesartan medoxomil500 in 1 BOTTLETABLET, FILM COATED5002
16729-394-17amlodipine besylate and olmesartan medoxomil1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-394AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.]24 package rows20220901_a855ce60-6918-490a-9158-3be5a0ef76b5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 116 of 121 · 2,412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine and ValsartanAMLODIPINE AND VALSARTANAlembic Pharmaceuticals Limiteda9c442dc-749e-4de0-bca3-1044eb78da722023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylate and Olmesartran medoxomilAMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMILAlembic Pharmaceuticals Limitedcb2df7f7-fee8-42ba-8936-0788c4fcc0cb2023-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 730872
rxcui: 730866
rxcui: 730861
rxcui: 730869
unii: 864V2Q084H
unii: 6M97XTV3HD
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited8c65d555-8db8-40d9-be30-309ef09f19be2023-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Olmesartan MedoxomilOLMESARTAN MEDOXOMILAlembic Pharmaceuticals Limitedac08ea7d-f529-42ca-850a-a0ecce7dc8302023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedf12f18bb-7ddb-e7dc-4edd-32f4ac212bca2022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedca014f06-982c-6fe1-9948-a3701dd35d342022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEUnichem Pharmaceuticals (USA), Inc.a516b336-8f60-4b86-8921-c7d6c07629f22022-12-05Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEProficient Rx LP29a0d87e-6afb-4766-9045-1963c5b0d1832022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCf3482709-c5c3-4bd0-8067-ad57f31bb5252022-10-18Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTANLupin Pharmaceuticals,Inc.e05dd72c-7475-422e-bf8e-73148929450e2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP445d1274-7249-476b-ad90-ff93aee56f6d2022-06-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d62022-04-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEExelan Pharmaceuticals, Inc.1a24433f-4464-4c6d-9456-ed1ce38e8ec42022-03-12Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILSolco Healthcare US, LLC.6e602f81-1cc3-4ae1-8bdf-85572e35cf732022-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS97e7ece8-a705-4988-ba52-6d3f115735212021-12-01WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 ChestnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS6a44f926-11b4-4bc4-8d5d-721a89c4f0cc2021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HazelnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASb58af664-b0fd-4585-8417-7c20954d7aff2021-11-09WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 UmberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS7bbd1334-fae8-4274-b927-a099af7643452021-11-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.